(27 days)
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No
The document describes a software application for viewing and manipulating ultrasound volume data. It focuses on basic image display, editing, measurement, and storage functions. There is no mention of AI, ML, or any related concepts like deep learning, neural networks, or automated analysis beyond simple caliper measurements. The description of functions and the lack of information on training or test sets further indicate the absence of AI/ML.
No
The device is a software application for viewing, editing, measuring, and storing ultrasound volume data. It is intended for diagnostic purposes and analysis, not for treatment or therapy.
Yes
Explanation: The device is described as a software application for the display and 3D visualization of ultrasound volume data, enabling users to "observe images and perform analysis using the ultrasound volume data acquired with specified diagnostic ultrasound systems." It's used for "viewing, editing, measuring and storing of volume data" by "trained professionals, including physicians, nurses, and technicians" to "review test results of patients." Its predicate device, WS80A Diagnostic Ultrasound System, explicitly includes "Diagnostic" in its name. All these points indicate its role in the diagnostic process by allowing analysis and review of diagnostic imaging data.
Yes
The device is described as a "standalone software product" installed on a PC, and its primary function is the display and analysis of ultrasound volume data exported from ultrasound equipment. While it interacts with data from a hardware device (ultrasound system), the device itself is solely the software application. The mention of a "USB dongle" for some functions does not negate its software-only nature, as the dongle is likely a licensing or security mechanism, not the core medical device hardware.
Based on the provided information, the 3D/5D Viewer is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The 3D/5D Viewer processes ultrasound volume data, which is generated by an ultrasound system and represents images of internal structures, not biological specimens like blood, urine, or tissue samples.
- The intended use is for viewing, editing, measuring, and storing ultrasound volume data. This is focused on image manipulation and analysis, not on performing tests on biological samples to diagnose diseases or conditions.
- The device description explicitly states it reviews and analyzes volume data exported from ultrasound equipment. This reinforces its role as a post-processing tool for imaging data.
While the software is used by trained professionals in a healthcare setting and aids in the interpretation of diagnostic information, its function is centered around the visualization and analysis of imaging data, not the testing of biological samples.
N/A
Intended Use / Indications for Use
3D/5D Viewer is a software application for the display and 3D visualization of ultrasound volume data derived from ultrasound system. It is designed to allow the user to observe images and perform analysis using the ultrasound volume data acquired with specified diagnostic ultrasound systems. It is intended to be used for viewing, editing, measuring and storing of volume data. Typical users of this system are trained professionals, including physicians, nurses. and technicians.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
3D/5D Viewer is a standalone software product, which can be installed on a laptop/PC with Microsoft Windows XP and 7. It allows the user to use their computer to review, analyze, edit, and measure the volume data exported from ultrasound equipment via storage media such as a USB drive. As the 3D/5D Viewer software reads 3D volume data, the users can review test results of patients more quickly and easily. This function allows them to check 3D image results without using an ultrasound system, which helps them conduct more tests with the ultrasound system.
Primary operating functions are:
- Display and editing of Volume data sets
- Data storage (image, volume data)
- Support simple Caliper (distance, Ellipse, 3 Distance volume)
Some functions that it need to USB dongle are:
- HDVI
- 5D Heart
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Ultrasound
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
trained professionals, including physicians, nurses. and technicians.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not applicable. The subject of this submission, 3D/5D Viewer, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other and are connected by a flowing line.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 29, 2015
Samsung Medison Co., Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street. NW BUFFALO MN 55313
Re: K151808
Trade/Device Name: 3D/5D Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 1, 2015 Received: July 2, 2015
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
For
Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K151808
Device Name 3D/5D Viewer
Indications for Use (Describe)
3D/5D Viewer is a software application for the display and 3D visualization of ultrasound volume data derived from ultrasound system. It is designed to allow the user to observe images and perform analysis using the ultrasound volume data acquired with specified diagnostic ultrasound systems. It is intended to be used for viewing, editing, measuring and storing of volume data. Typical users of this system are trained professionals, including physicians, nurses. and technicians.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.
1. Submitter's Information:
SAMSUNG MEDISON CO., LTD. 42, Teheran-ro 108-gil, Gangnam-gu, Seoul, Korea
Contact Person: Jiyoung, Kim Regulatory Affairs Manager
Telephone: 82.2.2.2194.1299 Facsimile: 82.2.556.3974
Data Prepared: April 27, 2015
2. Name of the device:
Common/Usual Name: Picture Archiving Communications System Proprietary Name: 3D/5D Viewer Classification Names: FR Number Product Code Picture Archiving Communications System 892.2050 LLZ
3. Identification of the predicate or legally marketed device:
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4. Device Description:
3D/5D Viewer is a standalone software product, which can be installed on a laptop/PC with Microsoft Windows XP and 7. It allows the user to use their computer to review, analyze, edit, and measure the volume data exported from ultrasound equipment via storage media such as a USB drive. As the 3D/5D Viewer software reads 3D volume data, the users can review test results of patients more quickly and easily. This function allows them to check 3D image results without using an ultrasound system, which helps them conduct more tests with the ultrasound system.
Primary operating functions are:
- · Display and editing of Volume data sets
- · Data storage (image, volume data)
- · Support simple Caliper (distance, Ellipse, 3 Distance volume)
Some functions that it need to USB dongle are:
- · HDVI
- · 5D Heart
5. Intended Uses:
3D/5D Viewer is a software application for the display and 3D visualization of Ultrasound volume data derived from Ultrasound system. It is designed to allow the user to observe images and perform analysis using the volume data acquired with specified diagnostic ultrasound systems. It is intended to be used for viewing, analyzing, editing, measuring and storing of volume data.
6. Technological Characteristics:
3D/5D Viewer is substantially equivalent with respect to safety, effectiveness, and functionality to the SonoView Pro™ (K031886) and WS80A Diagnostic Ultrasound System (K143089).
The device is a software application and does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets volume data being displayed. It is designed to allow the user to observe images and perform analysis using the volume data acquired with specified diagnostic ultrasound systems. It is intended to be used for viewing, analyzing, editing, measuring and storing of volume data.
These are described in detail in the technological characteristics comparison table as below.
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| -- | --------------------------------------------------------------------------- | -- | -- | -- |
| Feature | Subject Device | The primary predicate devices | The predicate devices |
|---|---|---|---|
| 3D/5D Viewer | SonoView ProTM | WS80A | |
| (K031886) | (K143089) | ||
| Computer Operating System | |||
| - Windows XP, 7 | Yes | Yes | Not applicable |
| Opening and saving files | |||
| - Type of file | |||
| *.mvl | Yes | Yes | Yes |
| *.sty | Yes | No | Yes |
| Functionality | |||
| - MPR | |||
| Slub 3D | Yes | Yes | Yes |
| Accept ROI | Yes | Yes | Yes |
| FAD | Yes | No | Yes |
| Curved ROI | Yes | No | Yes |
| - Mirror View | Yes | Yes | Yes |
| - MagiCut | |||
| Smooth Cut | Yes | No | Yes |
| - Volume Slice | Yes | Yes | Yes |
| - MSV | Yes | Yes | Yes |
| - Oblique View | Yes | Yes | Yes |
| - Volume CT | Yes | Yes | Yes |
| - VOCAL | Yes | Yes | Yes |
| - XI VOCAL | Yes | Yes | Yes |
| - Cine View | |||
| 3D Cine | Yes | Yes | Yes |
| 4D Cine | Yes | Yes | Yes |
| - 5D Functions | |||
| 5D NT | Yes | No | Yes |
| 5D CNS | Yes | No | Yes |
| 5D Follicle | Yes | No | Yes |
| 5D LB | Yes | No | Yes |
| 5D Heart | Yes | No | Yes |
| - Measurement | |||
| Distance | Yes | No | Yes |
| Ellipse | Yes | No | Yes |
| 3 Distance Volume | Yes | No | Yes |
| - Render Setup functions | |||
| Realistic Vue | Yes | No | Yes |
| VSI | Yes | No | Yes |
| - Post Processing functions | |||
| Post Gain | Yes | No | Yes |
| Clear SFVI | Yes | No | Yes |
| Detailed SFVI | Yes | No | Yes |
| HDVI | Yes | No | Yes |
| - Chroma map function | Yes | Yes | Yes |
7. A brief discussion of the non-clinical and clinical tests conducted on the subject device
The device has been evaluated to conform to applicable voluntary standards.
- IEC 62304 Medical device software Software life-cycle processes
- ISO 14971 Medical devices Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
- HIPAA COMPLIANCE 3D/5D Viewer is in compliance with the Health Insurance Portability and
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Accountability Act of 1996 (HIPAA).
- SAMSUNG MEDISON Software Development Procedure (DXQ2-0035K)
Summary of Clinical Tests:
Not applicable. The subject of this submission, 3D/5D Viewer, did not require clinical studies to support substantial equivalence.
8. Conclusion
SAMSUNG MEDISON CO., LTD. considers the 3D/5D Viewer to be as safe, as effective, and performance is substantially equivalent to the predicate devices.
- The 510(k) Pre-Market Notification for the 3D/5D Viewer contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.
- The device will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey.
- The submission contains the results of a hazard analysis and the potential hazards have been classified as Minor.